Writing in his firm's FDA Law Blog, Fleder discusses some of the briefs filed in U.S. v Caronia, in which Caronia was convicted of conspiring to introduce misbranded drugs into interstate commerce because the drugs allegedly did not have adequate directions for use.

The Medical Information Working Group, composed of 11 major drug companies, argued that there is significant ambiguity regarding what speech is proscribed by the Federal Food, Drug, and Cosmetic Act, as construed and applied by FDA and the Justice Department.

In its brief, Fleder says, the government contends that in off-label cases, it uses off-label speech as mere evidence of the manufacturer's intent.

Fleder says this shows that the government is trying to stretch a “directions for use” theory to prosecute people for off-label use promotion because the law is silent on whether it prohibits off-label promotion.